Notification report

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Application for deliberate release into the environment of genetically modified MIR604 insect resistant maize (Field Trials)

Proposed period of release:
01/04/2009 to 01/12/2014

Name of the Institute(s) or Company(ies)
Syngenta Agro SRL, Victoria Park
73-81 Bucureşti-Ploieşti Str.
Floor. 4, 013685
Bucharest, România
Tel: + 40 21 5281200
Fax: + 40 21 5281299;

3. Is the same GMPt release planned elsewhere in the Community?
Spain; Czech Republic;

Has the same GMPt been notified elsewhere by the same notifier?

If yes, notification number(s):
B/CZ/09/01; B/ES/03/13; B/ES/07/33; B/ES/08/33; B/RO/08/01;

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmays

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Event MIR604 is a genetically modified maize expressing a modified Cry3A (mCry3A) protein that confers protection against the Western Corn rootworm (WCR) (Diabrotica virgifera virgifer, LeConte), the Northern Corn rootworm (NCR) (Diabrotica longicornis barberi, Smith and Lawrence) and related Diabrotica species. It also expresses a marker gene, pmi, that encodes the enzyme phosphomannose isomerase (PMI) allowing the plants to utilise mannose as a carbon source, untransformed maize plants cannot use mannose, therefore PMI protein acts as a selectable marker when plants are grown on media containing mannose as the sole source of carbon.

Genetic modification

3. Type of genetic modification:

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
Promoter sequences: Promoter sequences from Zea mays. Provides root-preferential expression in Zea mays.

Insect tolerance gene: encodes a modified cry3A gene from Bacillus thuringiensis subsp. kurstaki which confers tolerance to certain coleopteran insect pests.

Selectable marker: E. coli pmi gene encoding the enzyme phosphomannose isomerase (PMI). Catalyzes the isomerization of mannose-6-phosphate to fructose-6-phosphate.

NOS terminator: Termination sequence of the nopaline synthase gene, isolated from Agrobacterium tumefaciens. The function of this sequence is to signal the termination of the gene expression.

6. Brief description of the method used for the genetic modification:
Event MIR604 was produced using immature maize embryos derived from a proprietary Zea mays line, via Agrobacterium - mediated transformation.

7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
Not applicable .

Experimental Release

1. Purpose of the release:
Field trial release of MIR604 insect resistant maize in Romania to be carried out with the objectives of omologating MIR604 maize varieties in the National Catalogue Of Varieties Of Agricultural Plant Species , gathering of necessary information regarding the agronomical performances, environmental compatibility of MIR604 maize varieties under geo-climatic conditions of Romania during 2009-2014. Another main objective of the field release in Romania is to assess the potential effects of event MIR604 on key non-target organisms when cultivated under European field conditions.

Testing of MIR604 insect resistant maize varieties during 2009-2014 is also carried out for comparative analysis (sampling of silage, grain, fresh vegetable material and pollen) and for the study of gene expression of genetically modified and non-genetically modified, conventional hybrids.

2. Geographical location of the site:
In Romania, the field trials will be conducted at eight (8) different location sites (2009-2014).

a) within the ISTIS network of 6 (six) centres for variety testing named hereafter CTS – CTS Dîlga (Călăraşi county), CTS Râmnicu Sărat (Buzău county), CTS Tecuci (Galaţi county), CTS Târgovişte (Dâmboviţa county), CTS Mircea Vodă (Brăila county) şi CTS Satu Mare (Satu Mare county)
b) within SCDA – Lovrin, Timis county
c) Cărpiniş, Timiş county

3. Size of the site (m2):
The field trials will be carried out in Romania in eight different locations between 2009 and 2014. The surface area planted with MIR604 genetically modified maize plants will be maximum 5000 sqm/location for comparative analysis, gathering of agronomical data, protein expression analysis and assessing the potential effects of event MIR604 on key non-target organisms when cultivated under European field conditions and, finally for registration of MIR604 maize varieties in the National Catalogue Of Varieties Of Agricultural Plant Species . In 2009, Syngenta will carry out field trials with only one MIR604 maize variety. In the following years, Syngenta will carry out field trials in România with different MIR604 hybrids.

4. Relevant data regarding previous releases carried out with the same GM-plant, if any, specifically related to the potential environmental and human health impacts from the release:
Event MIR604 has been evaluated by Syngenta in field trials in multiple locations in the North and South America and in Europe. No adverse effects on human health or the environment were reported.

MIR604 maize is currently cultivated in the USA, Canada and Japan with no adverse effects to the environment or on human health reported. Field trials with MIR604 genetically modified maize has been carried out in Romania beginning with 2008.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
An Environmental Risk Assessment study has been completed and submitted with the application. In summary, no immediate or delayed adverse effects as a result of the direct and indirect interaction of the genetically modified maize with the environment when compared to the non-modified maize have been identified.

Brief description of any measures taken for the management of risks:
•The experimental field trails will be conducted in areas where maize is not cultivated for the production of seeds;
• The isolation distance to other maize fields will be no less than 200 m;
•A minimum of 4 non-GM maize (conventional) rows will surround the field trials (buffer rows) to minimize pollen dispersal and act as a pollen trap;
•The plants growing in the buffer zone will not be used for human food or animal feed;
•Sowing and harvesting will be conducted under the supervision of Syngenta personnel trained on precaution measures;
•Carrying out regular visits to inspect field trails sites, making observations and verifying that adequate measures are applied for preventing pests and diseases;
•Harvesting and destroying of plant material remaining after sampling is complete;
•No seed products resulting from the field trails will be used as food or feed;
•After harvest Syngenta personnel will supervise the incorporation of any plant remains into the soil;
•The sites will be monitored for one year after the harvest and any volunteer maize appearing will be eliminated and destroyed using conventional herbicides or by mechanical mean before flowering. During this year, maize will not be grown on the trial sites.
•The following year no commercial maize cultivation will take place on the field trail location site.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The field trials will allow the further assessment of this maize in the environment and under geo-climatic conditions of Romania.

Final report

European Commission administrative information

Consent given by the Member State Competent Authority:
02/06/2009 00:00:00